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510(k) Data Aggregation

    K Number
    K014223
    Device Name
    MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM
    Manufacturer
    MEDTRONIC PERCUSURGE, INC.
    Date Cleared
    2002-01-25

    (30 days)

    Product Code
    NFA
    Regulation Number
    870.1250
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts to:

    • Contain and aspirate embolic material (thrombus/debris) while performing . Somain and aspenary angioplasty or stenting procedures.
    • To subselectively infuse/deliver diagnostic or therapeutic agents with or . without vessel occlusion.
    • · The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the PercuSurge GuardWire Plus Temporary Occlusion and Aspiration System. This document does not contain information regarding acceptance criteria for a device, nor does it detail a study proving the device meets said criteria.

    The letter only states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the indicated uses. It outlines the regulatory classification and general controls.

    Therefore, I cannot provide the requested information based on the input text. The information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in this document.

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